Rheumatrex (Methotrexate Sodium)

Do NOT use RHEUMATREX if:

• you are allergic to any ingredient in RHEUMATREX
• you are breast-feeding
• you are treating psoriasis or rheumatoid arthritis and any of the following apply to you:
  • you are pregnant
  • you have alcoholism, liver problems caused by alcohol, or chronic liver problems
  • you have a weakened immune system or certain blood problems (eg, anemia, bone marrow depression, low white blood cell count, low blood platelet count)
• you are taking acitretin
• you have taken or will be taking palifermin within 24 hours of taking RHEUMATREX

Contact your doctor or health care provider right away if any of these apply to you.

Before using RHEUMATREX:

Some medical conditions may interact with RHEUMATREX. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breastfeeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are able to become pregnant or father a child
• if you have a history of lung problems, immune system problems, nervous system problems (eg, seizures), liver problems (eg, hepatitis), kidney problems, diabetes, or blood problems (eg, anemia, low white blood cell levels, low blood platelet levels)
• if you have an active infection, severe vomiting or diarrhea, or dehydration
• if you have mouth sores, excess fluid in your stomach or around your lungs, stomach or bowel ulcers, bowel inflammation (eg, ulcerative colitis), or a blockage of your stomach or bowel
• if you have a folic acid deficiency, are in very poor health or are very overweight, or have a history of alcohol abuse
• if you are receiving chemotherapy or radiation

Important safety information:

• RHEUMATREX may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use RHEUMATREX with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Check with your doctor before you drink alcohol while you are taking RHEUMATREX.
• Nausea, vomiting, and loss of appetite are common with RHEUMATREX. Ask your doctor or pharmacist for ways to decrease these effects if they occur.
• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
• RHEUMATREX may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to RHEUMATREX. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• RHEUMATREX may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• RHEUMATREX may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Do not receive a live vaccine (eg, measles, mumps) while you are taking RHEUMATREX. Talk with your doctor before you receive any vaccine.
• RHEUMATREX may affect your ability to become pregnant or to father a child. Discuss any questions or concerns with your doctor.
• Men who take RHEUMATREX should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you take RHEUMATREX and for 3 months after you stop taking it.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Lab tests, including complete blood cell counts, liver function, and kidney function, may be performed while you use RHEUMATREX. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use RHEUMATREX with caution in the ELDERLY; they may be more sensitive to its effects.
• RHEUMATREX should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: RHEUMATREX may cause birth defects and fetal or newborn death if you take it while you are pregnant. Do not become pregnant while you are using it. Use an effective form of birth control while you take RHEUMATREX and for at least 1 ovulatory cycle after you stop taking it. If you think you may be pregnant, contact your doctor right away. RHEUMATREX is found in breast milk. Do not breast-feed while taking RHEUMATREX.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

• Dizziness; drowsiness; general body discomfort; headache; loss of appetite; mild hair loss; mild stomach pain; nausea; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

• Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; bone pain; calf or leg pain, redness, swelling, or tenderness; change in the amount of urine produced; chest pain; confusion; coughing up blood; diarrhea or vomiting; difficult or painful urination; dry cough; enlargement of the breasts (in males); fainting; fever, chills, or persistent sore throat; menstrual changes; mental or mood changes; mouth or tongue sores or swelling; muscle weakness; night sweats; one-sided weakness; red, swollen, peeling, or blistered skin; seizures; severe or persistent dizziness or light-headedness; shortness of breath; speech changes; swollen glands; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, severe stomach pain, yellowing of the skin or eyes); symptoms of pancreas inflammation (eg, severe stomach pain with or without nausea or vomiting); unexplained weight loss; unusual bleeding or bruising; unusual pain and discoloration of the skin; unusual tiredness or weakness; vaginal discharge; vision loss or other vision changes (eg, blurred vision); vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.

Some MEDICINES MAY INTERACT with RHEUMATREX. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Palifermin because if mouth or tongue sores develop, they may be more severe or last longer
• Medicines that may harm the kidney (eg, amphotericin B; tacrolimus; aminoglycoside antibiotics such as gentamicin) or the liver (eg, azathioprine; retinoids such as acitretin or isotretinoin; acetaminophen; ketoconazole; isoniazid; certain medicines for HIV infection) because the risk of kidney or liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney or liver
• Chloramphenicol, ciprofloxacin, corticosteroids (eg, prednisone), cyclosporine, dantrolene, hydantoins (eg, phenytoin), hydroxychloroquine, leflunomide, NSAIDs (eg, ibuprofen, celecoxib, ketorolac), penicillamine, penicillin antibiotics (eg, amoxicillin), phenylbutazone, pristinamycin, probenecid, proton pump inhibitors (PPIs) (eg, omeprazole), salicylates (eg, aspirin), sulfonamide medicines (eg, sulfamethoxazole, sulfasalazine), tetracycline antibiotics (eg, doxycycline), trimethoprim, or vancomycin because they may increase the risk of RHEUMATREX's side effects
• Folic acid because it may decrease RHEUMATREX's effectiveness
• Digoxin because its effectiveness may be decreased by RHEUMATREX
• Mercaptopurine, oral anticoagulants (eg, warfarin), or theophylline because the risk of their side effects may be increased by RHEUMATREX

This may not be a complete list of all interactions that may occur. Ask your health care provider if RHEUMATREX may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Use RHEUMATREX as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take RHEUMATREX by mouth with or without food. However, you should take it the same way each time in relation to food.
• Drinking extra fluids while you are taking RHEUMATREX is recommended. Check with your doctor for instructions.
• The dose of RHEUMATREX and how often you use it are based on your medical condition and response to treatment. It is very important that you follow your doctor's instructions carefully. Taking too much of RHEUMATREX may cause serious and sometimes fatal side effects. Be sure you understand exactly how much of RHEUMATREX to take and how often you should take it. Ask your doctor or pharmacist if you have any questions.
• It may take several weeks for the full benefit of RHEUMATREX to be seen in the management of psoriasis or rheumatoid arthritis. Do not stop taking RHEUMATREX without checking with your doctor.
• RHEUMATREX works best if each dose is taken at the scheduled time.
• Continue to take RHEUMATREX even if you feel well. Do not miss any doses.
• If you miss a dose of RHEUMATREX, contact your doctor right away. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use RHEUMATREX.

If OVERDOSE is suspected:

Contact your local poison control center or emergency room immediately. Symptoms may include black or bloody stools; change in the amount of urine produced; seizures; severe headache, nausea, vomiting, or stomach pain; swelling or soreness of the mouth or tongue; unusual bruising or bleeding; unusual tiredness or weakness; vomit that looks like coffee grounds.

Proper storage of RHEUMATREX:

Store RHEUMATREX at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep RHEUMATREX out of the reach of children and away from pets.